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Manager/Sr. Manager, Manufacturing
Brand: Avrio Biopharma
Req#: 164185
Updated: 01/28/2014
Job Type: Full Time
Location: Irvine, CA
Category: Operations
Salary: Salary
Benefits: Full Benefits
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Job Description

The Manager/Sr. Manager of Manufacturing will be responsible for ensuring organizational effectiveness by providing leadership for the organization's quality and manufacturing team. Contribute to the long- and short-term planning and strategy, working with the management team. This position will also interact with the corporate team to manage, measure, and assess goals and effectiveness in accordance with current Good Manufacturing Practices (cGMP), Quality System Regulations, Company Policies and expectations. Responsible for providing team leadership to a customer-focused team committed to increasing and improving quality and productivity. Assist with Process Development and production of drug products for clinical  studies. Operate and assist with the operation of various production equipment, including the autoclave, depyrogenation oven, vial washer, lyophilizer, as well as CIP and SIP systems.  Build and grow manufacturing organization in response to project load.  Hire and train key manufacturing personnel for unit manufacturing and aseptic filling operations. Initiate continuous project improvement. Write protocols, scientific reports, and other technical documents. Participate in the interpretation of data and collaboration with other departments. Position requires hands on work with equipment, completion of production records and attention to details in a manufacturing facility.  Other responsibilities as directed.

  • BS in Science, Engineering or related field.
  • 10+ Years of experience in aseptic filling technology related to parenteral/lyophilized products.
  • Ability to organize and operate filling, labeling and packaging equipment for production of therapeutic parenteral (injectable) products.
  • Ability to prepare contingency plans and future strategies proactively.
  • Knowledge of cGMP manufacturing requirements related to clinical production and commercial manufacturing.
  • Strong organizational skills required to manage a group of production operators and interact closely with Process Development and Quality Assurance for successful completion of Production lots.
  • Ability to work effectively and efficiently in a demanding, dynamic environment.
  • Excellent oral and written communication skills.
  • Extensive experience leading manager level staff and above.
  • Extensive experience in strategic/tactical planning.
  • Strong project management skills - ability to take programs from concept to execution, and manage all stages.
  • Superb attention to detail and ability to meet deadlines.
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